By Jim Dickinson

When a medical device firm submits a 510(k) premarket notification to FDA and then duly receives a not substantially equivalent (NSE) letter in response, it could be excused for thinking that the scientific data it included in its submission had been reviewed and found wanting.

But many times—and perhaps mostly—that’s not the case, according to a recent client update issued by Minneapolis-based law firm DuVal & Associates, which is also seeking industry resistance to a second FDA effort to change the 510(k) program.

In the update, the law firm says CDRH ignores the submitted data when it performs so-called “stage-gated reviews” on 510(k)s—cursory assessments that lead to NSE letters when a statutorily mandated full review of the data might actually help the device meet the substantially equivalent definition.

It is not acceptable for the center to make a legal or regulatory equivalence determination in a stage-gated review without looking at any data, DuVal & Associates contends.

“We know that FDA for decades did not apply ‘stage-gated reviews’ as they are being interpreted and applied by FDA today,” the firm writes in its client update. “Today FDA averts its eyes, ears and does not even speak about data if it can avoid it . . . The statute and regulation actually require that FDA consider all ‘the information submitted’ to it, not some of it, or the amount FDA chooses in its discretion to review.”

The firm says that the statute doesn’t compel the agency to do a stage-gated review “and determine, on its own without ever looking at data, whether the device meets the statutory definition.”

“It is to be based upon a review of ‘the information submitted to FDA,’ without limitation or qualification,” the firm contends. “So FDA must look at all the information submitted to it in making its determination of whether the new technological characteristic raises different questions of safety and effectiveness and the data support a clearance.”

The firm also shoots down the possibility that the agency is conducting stage-gated reviews in an attempt at efficiency. “. . . actually FDA is short-changing the applicant and itself, because FDA may actually learn something from the data. Moreover, sponsors are paying for the more thorough review,” the firm writes.

DuVal & Associates also argues that Congress had intended CDRH to review 510(k)-submitted data in making substantial equivalence determinations.

“FDA as an organization is normally data-driven, but FDA seems to want to be able to make a judgment call on whether different questions are raised based upon its lone impression, without the benefit of data,” it says. To avoid doing so relies too much on “FDA intuition,” and this can “vary by CDRH divisions and the individuals whom FDA employs—some with vast experience and some quite naive and inexperienced,” it adds.

The law firm further contends that staged-gated reviews were spawned by CDRH’s 1986 Guidance on the CDRH Premarket Notification Review Program (K86-3), which was written when many argued that no data were necessary to even make a substantial equivalence determination.

DuVal & Associates notes that the guidance said the center “normally will require performance testing data to substantiate equivalence if a new device has an important descriptive difference in comparison to marketed devices within its type, and it is not clear from an initial review that the device has an intended use or technological change that makes it NSE….”

Saying it will normally require performance data “creates a presumption that FDA should review the data and not the other way around,” the firm says.

In a second attack on CDRH efforts to change the 510(k) program, DuVal & Associates in July urged AdvaMed and the Medical Device Manufacturers Association to oppose CDRH’s recent draft guidance on 510(k) benefit-risk factors “because it continues the assault on and erosion of the 510(k) program as we have known it.”

In the document, Benefit-RiskFactors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, the firm says the agency is again “essentially attempting to do indirectly what it cannot do directly, because it is not a legislative body, i.e. it cannot legislate change through its administrative interpretation of the 510(k) program.”

The firm contends that while guidance documents are intended to help industry understand the agency’s thinking on the 510(k) program, they instead result in changes and further muddy the waters, as well as often require companies to submit even more data.

“In short, FDA is, once again, over-thinking the 510(k) program,” the firm concludes.

Jim Dickinson is MD+DI's contributing editor.

[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]